Deploying POKE Within Intermountain Healthcare

Newborn; Infection Clinical Trial

— POKE  

Official title:

Deploying POKE Within Intermountain Healthcare

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03688607
• Other study ID #: IHC IRB #1050915
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2018
• Source: Intermountain Health Care, Inc.
• Contact: R. Erick Ridout, MD
• Phone: 435-705-9208
• Email: Erick.Ridout[@]imail.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the impact of POKE on babies, the investigators will longitudinally track outcomes before and after implementation at Intermountain Healthcare's five NICUs. Process outcomes will include the number of total POKEs per baby and the number of painful POKEs per baby, each measured at both the patient-level and NICU-level. Clinical outcomes will include hospital acquired infections, length of stay, and mortality. Financial outcomes will include total variable costs and backfill rate. The effect of POKE on each of these outcomes will be measured using multivariable regression analysis with appropriate distributional families and interaction terms.

Description:

POKE was developed and implemented at Dixie Regional Medical Center's Neonatal Intensive Care Unit (NICU) over the past 10 years to eliminate waste and reduce harm in healthcare. POKE is a combination of a unique culture and process, with a supporting database, that is designed to guide and inform care decisions while minimizing POKEs. The program utilizes an implementation framework, educational materials, electronic health records (EHR), and decision support analytics. POKE's initial deployment showed extremely promising results for Intermountain, which included: (1) eliminating 11,000 POKEs per year (a 50% reduction in overall POKEs), (2) realizing $940,000 per year in cost savings (a 28% reduction of overall cost), (3) reducing length of stay by 2 weeks per average stay (a 21% reduction in length of stay), and (4) eliminating Hospital Acquired Infections (i.e., Central-line Associated Bloodstream Infection and Ventilator-associated Pneumonia), translating into 10 lives saved and a $5.2M savings over a decade. POKE will now be deployed and routinized within all Intermountain Healthcare NICUs and be developed as a commercial product for external customers. To assess the impact of POKE on babies, the investigators will longitudinally track several outcomes before and after implementation at Intermountain NICUs. Process outcomes will include the number of total POKEs per baby and the number of painful POKEs per baby, each measured at both the patient-level and NICU-level. Clinical outcomes will include hospital acquired infections, length of stay, and mortality. Financial outcomes will include total variable costs and backfill rate.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2600
• Est. completion date: May 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• All babies in Intermountain Healthcare NICU

Exclusion Criteria:

Related Conditions & MeSH terms

• Newborn; Infection

Intervention

Procedure:
• There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.
There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.

Locations

Country	Name	City	State
United States	Dixie Regional Medical Center, Intermountain Healthcare	Saint George	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

Berwick DM, Hackbarth AD. Eliminating waste in US health care. JAMA. 2012 Apr 11;307(14):1513-6. doi: 10.1001/jama.2012.362. Epub 2012 Mar 14. — View Citation

Critical Care Statistics. Retrieved from http://www.sccm.org/Communications/Pages/CriticalCareStats.aspx

Ebell MH, Sokol R, Lee A, Simons C, Early J. How good is the evidence to support primary care practice? Evid Based Med. 2017 Jun;22(3):88-92. doi: 10.1136/ebmed-2017-110704. Epub 2017 May 29. — View Citation

Harrison W, Goodman D. Epidemiologic Trends in Neonatal Intensive Care, 2007-2012. JAMA Pediatr. 2015 Sep;169(9):855-62. doi: 10.1001/jamapediatrics.2015.1305. Erratum in: JAMA Pediatr. 2015 Sep;169(9):878. — View Citation

Institute of Medicine, 2013. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: The National Academies Press. https://doi.org/10.17226/13444

Kornhauser, M., & R. S. (2017, December 15). How Plans Can Improve Outcomes And Cut Costs for Preterm Infant Care. Retrieved from https://www.managedcaremag.com/archives/2010/1/how-plans-can-improveoutcomes-and-cut-costs-preterm-infant-care

National Center for Health Statistics. (2018, January 31). Retrieved from https://www.cdc.gov/nchs/nvss/births.htm

Special Care Nursery Admissions. (2011). National Perinatal Information Center Quality Analytic Services. Retrieved from https://www.marchofdimes.org/peristats/pdfdocs/nicu_summary_final.pdf

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of POKEs per baby	The primary outcomes will be the number of total POKEs per baby and the number of painful POKEs per baby. We will assess the impact of POKE on each of these outcomes modeled as counts (ie, generalized Poisson distributions) using multivariable regression adjusting for potential confounders including age, gestational age, interaction terms, and nominal indicators of NICU (to account for baseline heterogeneity across sites).	1 October 2018 - 31 May 2019
Secondary	Infection Rate	Also using multivariable regression, the secondary outcomes will be patient-level indicators, including hospital acquired infection (logistic regression)	1 October 2018 - 31 May 2019
Secondary	Length of Stay	Length of stay (scaled beta regression)	1 October 2018 - 31 May 2019
Secondary	Mortality	Mortality (logistic regression)	1 October 2018 - 31 May 2019
Secondary	Total Variable Cost	Total variable costs (log-linear regression)	1 October 2018 - 31 May 2019
Secondary	Aggregate Backfill Rate	aggregated backfill rate (quasibinomial regression)	1 October 2018 - 31 May 2019